Status:
TERMINATED
GRN1005 in Non-Small Cell Lung Cancer (NSCLC) Patients With Brain Metastases (GRABM-L)
Lead Sponsor:
Angiochem Inc
Conditions:
Non-small Cell Lung Cancer (NSCLC) With Brain Metastases
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to assess the efficacy, safety, and tolerability of GRN1005 in patients with brain metastases from non-small cell lung cancer (NSCLC).
Eligibility Criteria
Inclusion
- Key
- Adult patients (≥ 18 years)
- Histologically or cytologically-documented NSCLC (EGFR mutation status must be known)
- Brain metastases from NSCLC, which:
- have radiologically-progressed after WBRT or are present without prior WBRT
- At least one radiologically-confirmed and measurable lesion (≥ 1.0 cm in the longest diameter) within14 days prior to the first dose of GRN1005 (Cycle 1, Day 1), as follows: an intra-cranial disease lesion (≥ 1.0 cm in the longest diameter) confirmed by Gd-MRI, or an extra-cranial disease lesion (≥ 1.0 cm in the longest diameter) confirmed by MRI or CT scan with contrast Prior stereotactic radiosurgery (SRS) is allowed; however, metastatic brain lesions previously treated with SRS are not allowed as target or as non-target lesions.
- Patients must be neurologically stable, defined as being on stable doses of corticosteroids and anticonvulsants (not EIAEDs, including phenytoin, phenobarbitol, carbamazepine, fosphenytoin, primidone, oxcarbazepine) for ≥ 5 days prior to obtaining the baseline Gd-MRI of the brain and ≥ 5 days prior to first dose of GRN1005 (Cycle 1, Day 1).
- Karnofsky Performance Score (KPS) ≥ 80%
- Completed WBRT for intra-cranial lesions ≥ 28 days prior to first dose of GRN1005 (with the exception of local radiation therapy for palliation to extra-cranial sites, i.e., bone). All clinically significant toxicities must have resolved to ≤ NCI CTCAE v4.0 Grade 1.0.
- Key
Exclusion
- NCI CTCAE v4.0 Grade ≥ 2 neuropathy
- CNS disease requiring immediate neurosurgical intervention (e.g., resection, shunt placement, etc.)
- Known intra-cranial hemorrhage
- Known leptomeningeal disease
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2013
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT01497665
Start Date
November 1 2011
End Date
February 1 2013
Last Update
January 22 2019
Active Locations (10)
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1
Univ. of California San Diego
La Jolla, California, United States, 92093
2
Univ. Coloardo at Denver
Aurora, Colorado, United States, 80045
3
H. Lee Moffitt Cancer Center
Tampa, Florida, United States, 33612
4
Northwestern Univ.
Chicago, Illinois, United States, 60611